Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Monovalent Avian Influenza VLP · 4 trials · 2 indications
Counts (and percentages) of subjects with solicited local and systemic AEs over the seven days post-injection and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 42 days post-first injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year.
Geometric mean titer (GMT) Geometric mean ratio (GMR) Seroconversion rate (SCR) Seroresponse rate (SRR)
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Placebo |
| Group B | EXPERIMENTAL | High dose Monovalent Avian Influenza VLP (H7N9); IM; Day 0 and Day 21 |
| Group C | EXPERIMENTAL | High dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
| Group D | EXPERIMENTAL | Intermediate dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
| Group E | EXPERIMENTAL | Low dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
| Group F | EXPERIMENTAL | High dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
| Group G | EXPERIMENTAL | Intermediate dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
| Group H | EXPERIMENTAL | Low dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21 |
| Name | Type | Description |
|---|---|---|
| Monovalent Avian Influenza VLP (H7N9) | BIOLOGICAL | - |
| Matrix-M1™ adjuvant | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
| Adjuvant 1 | BIOLOGICAL | - |
| Monovalent Avian Influenza VLP (H5N1) | BIOLOGICAL | Dose A without Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21 |
| Monovalent Avian Influenza VLP (H5N1); Adjuvant | BIOLOGICAL | Dose B with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21 |
| Saline Placebo | BIOLOGICAL | Placebo; intramuscular, deltoid, Day 0 and Day 21 |
Inclusion Criteria: 1. Healthy adult male or female, 18 to 64 years of age, 2. Willing and able to give informed consent prior to study enrollment, 3. Able to comply with study requirements, and 4. Women of child-bearing potential must have a negative urine pregnancy test prior to each vaccination,...
Monovalent Avian Influenza VLP is an investigational vaccine being developed for pandemic influenza and avian influenza. It is designed to protect against influenza strains with pandemic potential, including A/H5N1 and A/H7N9 subtypes. The vaccine is currently in Phase 1 clinical development and has not been approved for commercial use.
Monovalent Avian Influenza VLP is being developed by Novavax, Inc., a biotechnology company traded on NASDAQ under the ticker symbol NVAX. Novavax is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in healthy adult volunteers.
Monovalent Avian Influenza VLP is in Phase 1 clinical development. All three completed trials were Phase 1 studies, and there are no active trials currently enrolling. The vaccine remains investigational and has not received FDA approval or any other regulatory approval.
Monovalent Avian Influenza VLP has completed three Phase 1 trials. NCT01594320 and NCT01596725 evaluated A/H5N1 virus-like particle antigen with adjuvant in the United States, enrolling 333 participants each. NCT01897701 and NCT02078674 studied A/H7N9 VLP antigen with adjuvant in Australia and the United States, enrolling 280 and 610 participants respectively.
Monovalent Avian Influenza VLP is a virus-like particle vaccine that mimics the structure of influenza viruses without containing genetic material. This approach is designed to stimulate an immune response against specific avian influenza strains, potentially providing protection against pandemic influenza. The vaccine is administered with an adjuvant to enhance the immune response.